Quality Compliance Specialist

Job Summary

A company is looking for a Quality Compliance Specialist, Complaint Handling & MDR Reporting.

Key Responsibilities

• Evaluate global complaint information and conduct investigations as needed
• Prepare and submit Medical Device Reporting (MDR) reports to the FDA
• Lead projects to improve processes and manage customer relationships during complaint investigations

Required Qualifications

• Bachelor's degree plus three years of experience in complaint handling and MDR evaluation, or equivalent work experience
• Experience in the medical device or healthcare industry
• Knowledge of Good Documentation Practices (GDP) related to complaint filing
• Familiarity with 21 CFR 820 & 803 regulations
• Proficient in MS Office Suite and general office machinery